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Food and Drug Administration, HHS.
Notice of roundtable discussion; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile ( e.g., pharmacokinetic studies), studies of adult benefit ( e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile ( e.g., estimated lifetime cancer risk). The purpose of the roundtable is to provide manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. This notice provides information on meeting participation and selection. FDA is establishing a docket for public comments related to the roundtable meeting.
The roundtable meeting will be held on February 10, 2026, 9:00 a.m. to 5 p.m., Eastern Time. Electronic or written comments on the roundtable may be submitted beginning December 29, 2025. See the SUPPLEMENTARY INFORMATION section for registration date and information.
The roundtable meeting will be held in the White Oak Great Room and virtually. Entrance for the roundtable panelists (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 3, 2026, to be considered for the roundtable discussion. All other electronic comments must be submitted on or before March 12, 2026. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 12, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before these dates.
The public can submit comments on the roundtable topics during the open comment period; the request for comments is not limited to small tobacco product manufacturers.
You may submit comments as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2025-N-7022 for “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received, timely comments (see ADDRESSES ) will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Daniel Gittleson, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email: CTPRegulations@fda.hhs.gov.
Tobacco products that meet the definition of a “new tobacco product,” and that an applicant intends to market in the United States, including ENDS, are subject to the requirements for a PMTA set forth in section 910(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). When reviewing PMTAs, the Agency evaluates, among other things, a tobacco product's components, ingredients, additives, constituents, design, harmful and potentially harmful constituents (HPHCs), and health risks, as well as how the product is manufactured, packaged, and labeled. After reviewing a company's PMTA, FDA determines if the application includes or lacks sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), which is the applicable legal standard required by the FD&C Act (see section 910(c) of the FD&C Act).
Through this notice, FDA announces a roundtable discussion to gather feedback from small tobacco product manufacturers (see 21 U.S.C. 387(16)) about their experience with, and other opinions about, the premarket application process. The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile ( e.g., pharmacokinetic studies), studies of adult benefit ( e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile ( e.g., estimated lifetime cancer risk (ELCR)). FDA also is establishing a public docket to solicit comment on these topics.
The purpose of the roundtable is to provide small ENDS manufacturers an opportunity to share their experience and other opinions about the premarket application process. Roundtable topics to be discussed include certain components of ENDS PMTAs, such as product characterization, manufacturing controls, pharmacological profile ( e.g., pharmacokinetic studies), studies of adult benefit ( e.g., longitudinal cohort/RCT studies), and toxicological profile ( e.g., ELCR).
The foundational information necessary to evaluate the quality and consistency of a new tobacco product is based on an understanding of the product as delivered to the user. One of the critical pieces of information is a complete product listing and description, including details of the product design. Also included in ENDS product characterization is the measurement of constituents in the aerosol, including HPHCs, which provide details of a user's exposure to nicotine and other potentially harmful ingredients. This roundtable will discuss the types of information needed to fully characterize a product in an application and can cover topics including product formulation, validation of analytical measurements, and the assessment of leachables and extractables, where appropriate.
In addition to product characterization, a complete understanding of a manufacturer's internal controls and practices is important for FDA to ensure that products delivered to a user will be sufficiently similar to the products that were tested and that form the basis of our scientific assessment of nicotine and potential toxic constituent exposure from the new product. This information includes standard operating procedures (SOPs); work instructions; certificates of analysis; the linkage between label claim and actual measured nicotine delivery; and stability of new products during storage, transport, and shelf life, and these are all topics which may be covered and discussed in the roundtable.
One of the most important aspects of FDA's evaluation of APPH for a new tobacco product focuses on the abuse liability of the new tobacco product including the delivery and uptake of nicotine by a user of the product. Nicotine exposure typically is evaluated through clinical studies that evaluate nicotine pharmacokinetics after use of the new tobacco product. Occasionally, it is possible to bridge the findings of one ENDS product to another, thus allowing a reduction in the number of studies needed to support a product. However, the proper designs of these clinical studies for ENDS products can be complex and need to be highly developed before work is initiated. This roundtable will address criteria that could improve the quality of the clinical studies for ENDS products submitted by applicants and provide participants an opportunity to ask questions about design basics to inform their applications.
The understanding of the potential benefits that a new ENDS tobacco product may offer to users of combusted tobacco products by switching to the new ENDS tobacco product is critical to FDA's APPH determination. Examples of population studies to assess switching include longitudinal cohort studies or randomized controlled trials of the new tobacco product with adult users. This roundtable will include a discussion of the critical considerations in the design and administration of these adult benefit studies.
The toxicological assessment of a new tobacco product application for APPH includes a careful evaluation of critical elements of potential and actual risk posed by the use of the product. These critical elements typically include, among other topics, the hazard identification and associated risk assessment of HPHCs found in the aerosol of ENDS products and the risks associated with constituents in a new product. This roundtable will discuss approaches that an applicant could use to evaluate their products for potential risks from a genotoxicity approach (ELCR), inhalation toxicity, and HPHC exposure.
Registration for the roundtable is open to small tobacco product manufacturers as defined in section 900(16) of the FD&C Act. The term “small tobacco product manufacturer” means a tobacco product manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a manufacturer under the preceding sentence, the employees of a manufacturer are deemed to include the employees of each entity that controls, is controlled by, or is under common control with such manufacturer. For example, if a parent company owns two subsidiaries, the total number of employees would include the employees in the parent company plus the number of employees in the two subsidiaries. Additionally, registration for participation in the roundtable will be limited to 30 participants ( printed page 60717) representing manufacturers who have previously submitted an ENDS PMTA, including those with a PMTA currently pending with FDA. Final eligibility for attendance will be determined by FDA. Participants should be at a sufficiently senior level with significant scientific and/or regulatory responsibility to be knowledgeable about their company's PMTA.
Registration: Registration is free. For information on how to register for the roundtable as a panelist, please visit the following website: https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery, by January 27, 2026, 11:59 p.m. Eastern Time. Registrants should include the following information for the attendee in their request to participate in the roundtable:
A. Product Characterization
B. Manufacturing Controls
C. Pharmacological Profile
D. Studies of Adult Benefit
E. Toxicological Profile
Registration for panelists is on a rolling basis determined by space availability, with priority given to early registrants. FDA will evaluate registrations based on the submitted information until a maximum of 30 participants have been selected for the roundtable and will then inform applicants of selection decisions. Due to time and space constraints, there is a limit of one person to represent and speak on behalf of each company. Panel registrants will receive confirmation as to whether they have been accepted. If panelist registration closes prior to the submission deadline, we will update the website to reflect that change. For persons interested in viewing the roundtable virtually, information will be provided on our website: https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery.
If you need special accommodations due to a disability, please email: CTP-OS-ACS@fda.hhs.gov no later than February 3, 2026.
Virtual Participation and Live Streaming of the Roundtable: This roundtable will also be available for virtual attendance. If you have been accepted to participate in the roundtable meeting as a panelist but will attend virtually, you will receive details prior to the roundtable. For non-panelist attendees interested in viewing the roundtable virtually, information will be provided on our website: https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery.
Transcripts: Please be advised that as soon as a transcript of the roundtable is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the internet at https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-23851 Filed 12-23-25; 8:45 am]
BILLING CODE 4164-01-P
16 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.